Experts, Citizens and Eurocrats

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Experts, Citizens, and Eurocrats Towards a Policy Shift in the Governance ofBiopolitics in the EU

Gabriele Abels

European Integration online Papers (EIoP) Vol. 6 (2002) N 19;http://eiop.or.at/eiop/texte/2002-019a.htm

Date of publication in the : 3.12.2002

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Keywords

sectoral governance, RTD policy, new technologies, civil society, democratization, EuropeanCommission, European Parliament, expert committees, legitimacy, risk regulation, political science

Abstract

The hypothesis put forward in this paper is that we are currently observing a remarkable policyshift in the European Community concerning the conceptual basis and instruments for thegovernance of biopolitics. Biopolitics refers to an emerging policy field which involves the societalconflicts over the application of new genetic and reproductive technologies to humans(biomedicine) as well as the application of these new technologies particularly to agriculture andfood production (biotechnology). The changes refer to the basic concept of how to govern therelationship between science and society, experts and lay-people, citizens and Eurocrats. The EC isopening up for incorporating ethical concerns into its research, technology and development policyas well as its regulatory biopolicies; furthermore, there is growing openness for participatoryforms of biopolicy-making, yet the meaning of participation is limited. The reasons for thisdevelopment are to be found in a more general trend in the transformation of European governanceon the one hand aiming at involving civil society actors, and, on the other hand, in the

characteristics of the policy field. These visions, spread out in the Commissions White Paper onEuropean Governance and several related policy papers, prove to be challenging for the Union asdynamic and multi-level polity.

Kurzfassung

In diesem Beitrag wird die These vertreten, dass wir gegenwrtige eine bemerkenswerteVernderungen im Hinblick auf die konzeptionelle und instrumentelle Ausgestaltung der Biopolitikin der EU beobachten knnen. Biopolitik bezeichnet ein neues Politikfeld, welches sowohl dieAnwendung von genetischen und Fortpflanzungstechnologien am Menschen (Biomedizin) umfasstals auch die Anwendung dieser Technologien speziell in der Landwirtschaft undLebensmittelproduktion (Biotechnologie). Die Vernderungen betreffen die Regulierung der

Beziehung (governance) zwischen Wissenschaft und Gesellschaft, zwischen Experten und Laien,zwischen Brgern und Eurokraten. Die EG ffnet sich fr eine Inkorporierung von Ethik in ihreForschungsfrderpolitik und in ihre regulative Biopolitik sowie gegenber neuen Modi vonGovernance in Gestalt von partizipativen Verfahren, wobei hier ein verengterPartizipationsbegriff zugrunde gelegt wird. Die Grnde hierfr liegen zum einen in demallgemeinen Trend einer Transformation von europischen Governance-Strukturen und einerBeteiligung zivilgesellschaftlicher Akteure, zum anderen in den Charakteristika von Biopolitik.Diese Visionen der Europischen Kommission, die sie sowohl im Weissbuch EuropischesRegieren als auch in damit zusammenhngenden Dokumenten ausbreitet, sind eineHerausforderung fr die EU als einem dynamischen Mehrebenensystem.

The author

Dr.Gabriele Abels is a senior resarcher at the Institute for Science and Technology Studies (IWT),Faculty for Sociology, Bielefeld University; email: [email protected]; Homepage:http://www.uni-bielefeld.de/iwt/ga

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Contents:

z 1 Introduction: Biopolitics in the European Unionz 2 Dimensions of biopoliciesz 3 Biopolitics and the development of European TA

{ 3.1 Development of European TA{ 3.2 Biomedicine a catalyst for the development of European TA{ 3.3 Characteristics of supranational TA and policy-making

z 4 Regulatory biopolicies between science and participationz 5 Contextualising the participatory shift: Reforming European governance

{ 5.1 Challenges and principles of European governance: the White Paper{ 5.2 Science and society sectoral visions for European governance{ 5.3 Visions for the governance of biopolitics

z 6 Conclusionsz References

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1 Introduction: Biopolitics in the European Union

The question who should be involved in policy- and decision-making and what is the properrelationship between experts, lay-people and politicians is fundamental to democracies. Due to thestrong tradition for deliberation and direct democracy in modern political theory and in public

policy, there is a tendency to make policy- and decision-making more open to participation not onlyby stakeholders, but also by citizens. While this is essentially an old debate dating back to the Greek

polis, it has been renewed with regard to advanced technologies in the last decades. Claims forinvolving a variety of social actors have been raised and the role of science particularly in regulatory

policy-making has been widely discussed first in the US since the 1970s and for some years also inEurope. Biotechnology is an outstanding example, because of the alleged social impacts and,

partially, unpredictable environmental and health risks which has even enforced the generalparticipatory shift in technology assessment (TA) and policy-making. A variety of procedures hasbeen conceptually and methodologically developed as well as practically tested that turn the focusfrom the traditional policy advice function of TA to the creation of a public sphere; the aim is to getcitizens involved in discourses on science and technology.

For some years biotechnology and biomedicine and their political regulation (biopolicies) have

served as a hot issue in all member states of the European Union (EU) so that a dynamic biopoliticalarena emerged.(1) For example, Eurobarometer 52.1 on The Europeans and biotechnology, thefourth survey in a series that cover biotechnology since the 1990s, shows that there is generally a

Experts, Citizens, and Eurocrats Towards a Policy Shift in the Governance ofBiopolitics in the EU(*)

Gabriele Abels

European Integration online Papers (EIoP) Vol. 6 (2002) N 19;http://eiop.or.at/eiop/texte/2002-019a.htm

Date of Publication in : 3.12.2002

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high acceptance of so-called red biotechnology or biomedicine, while there is a far greater and,over time, even growing scepticism against green (agricultural) biotechnology in the late 1990s(cf. Durant et al., 1998; Gaskell/Bauer, 2001). Scepticism towards biomedicine and biotechnologyfocuses mainly not on the technology as such but on particular applications judged against thecriteria of usefulness, supposed risks, and moral acceptability: While the vast majority is downrightagainst genetically modified (GM) food, most people assess the detection of hereditary diseases as agood and morally acceptable purpose. However, some biomedical applications are regarded, in fact,as morally difficult, especially cloning and research on human embryos as well as the use of geneticdiagnosis for preimplantation genetic diagnosis. The politicisation of green biotechnology does notmean that red biotechnology is immune to public opposition. On the contrary, the possibility of

predictive medicine (e.g. genetic testing) has lately become an issue of public debate, for example, inDenmark, France, Germany and the Netherlands. Embryo and embryonic stem cell research are

particularly contested matters in most member states and also at the supranational level in the

context of the 6th Framework Programme for research, technology, and development (RTD). Notonly the members states but also the European Community (EC) has to tackle these questions withregard to its RTD and its regulatory policy. Community competences in both areas have immenselyincreased. This is primarily an outcome of the common market as the central project of Europeanintegration. Public support for, in particular of advanced technologies, is thought to be vital for thecompetitiveness of European economy.

The hypothesis that I want to put forward is that we are observing a remarkable shift particularly inthe Commissions position on how to govern biopolitics. Participation is the key word yetreduced to a very limited concept, as I shall illustrate. The proposed participatory modes ofgovernance aim at greaterinclusiveness of social actors, i.e. experts and lay-people, stakeholders andcitizens, the public and Eurocrats in supranational policy-making and regulation. The underlyingassumption is that the effectiveness and efficiency, i.e. the output-side of policy-making, can beimproved by strengthening the input-side and, in so doing, the legitimacy of EU policies willincrease. This policy shift is particularly relevant in the area of biopolitics due to the ongoing

political struggle especially over genetically modified (GM) food on the one hand and the assumedeconomic benefits on the other. Yet, it takes place within a fundamental discourse on Europeangovernance recently promoted, above all, by the European Commission which goes far beyond

biopolitics and which has effects on the concept and limits of participation.

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Since any analysis of societal conflicts over new technologies has to take the very technologicalcharacteristics into account, I will first sketch the conflict dimensions involved (section 2). I willthen illustrate the historical development of biopolicies in the EU starting with research policy andthe development of European TA (section 3) before I turn to the development of regulatory policy-making in this field (section 4). I will then introduce and analyse the relevant documents ongovernance and, in particular, on science and society published by the Commission over the last twoyears (section 5). In the final part, I will draw some conclusions for European governance (section6).

2 Dimensions of biopolicies

For a long time, EU policy-makers attributed the lack of acceptance of and resistance to biomedicineand biotechnology to peoples insufficient knowledge and irrational fears. A good example is the

Bangemann report on the promotion of a competitive environment for biotechnology, it states:

"At the same time, biotechnology suffers from a bad image amongst policy-makers andthe general public Although some of the expressed fears seem exaggerated they are,




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nonetheless, of great political influence. It is imperative therefore that problems ofpublic acceptability, and ethical questions raised, be recognised and dealtwith." (Commission, 1991, p. 41)

Policy measures focusing on better public relations and information campaigns are then judged to bemajor instruments for promoting social acceptability. This 'deficit model' blames the public for itsignorance as to the merits of science. However, Eurobarometer surveys illustrate that there is nolinear relationship between knowledge and social acceptability: an increase in knowledge does notgo hand in hand with an increase in acceptability.

The public controversy over biomedicine and biotechnology (biopolitics) is strongly influenced bythe very policy characteristics; three dimensions are deeply intermingled especially with regard to

biomedicine, but also in biotechnology (cf. also Gill/Dreyer, 2001):

Cognitive dimension: How can societies take decisions under the condition of intrinsic cognitiveuncertainty, e.g., in relation to health risks associated with gene therapy or environmental hazardsresulting from the deliberate release of genetically modified organisms (GMOs)? What doesepistemological uncertainty and the knowledge about the inherent limits of scientific knowledgemean for the management of risks? There is a strong, ongoing trend towards a 'scientification of

politics', i.e. the inflationary use of scientific expertise in public policy-making. Simultaneously, weobserve the 'politicisation of science': the competition between expertise and counter-expertisereveals that science is not an objective and value-free endeavour, but a socially constructed sphere.Science has lost it authority, yet, policymakers still rely on it for advice (cf. Weingart, 1999).Furthermore, risk research, which is so prominent with respect to biotechnology and biomedicine,does have a cognitive bias. This holds also true for the precautionary principle which is regarded as amanagement instrument to deal with this epistemological problem. Yet, risk research and riskmanagement both assume that the regulation of risks can be encountered by increasing knowledge;they underestimate the fact that the lackof knowledge is a basic component and requires new modesin the management of knowledge as well as a higher reflexivity of regulatory law and practices (cf.

Bora, 2002).

Interest dimension: Decisions over scientific and technological trajectories always involve conflictsof interest. For example, scientists are interested in doing research, medical doctors aim to help their

patients, and industrialists want to sell new products and services; while patients groups want tobenefit from new therapies and demand individual choices, activists of the disability movement feargenetic discrimination or compulsory use of biomedical applications once they are on the market.While environmental groups often want to ban genetically engineered food, industrialists want to usethe new technologies in food processing but depend on a reliable regulatory frame that addressesstandards and requirements. Policy-makers have to balance these opposing interests and have to keepthe common good in mind. They must develop policies which satisfy social needs and do not lead to

permanent social conflicts.

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ormative dimension: Risks deriving from technological inventions are perceived and judgeddifferently according to social norms and cultural practices. In risk regulation 'objective' scientificvalues are intertwined with more normative considerations. The acceptability of risk must therefore

be weighed against normative values which are often strongly rooted in national traditions andcultures. (Vos, 1999, p. 30) At the same time, dissent over fundamental normative issues could be a

constant source of social conflict. Thus, how do liberal societies respond to such issues? What kindof procedures are suitable for solving the principal dilemma that the 'law' cannot resolve thecognitive dimension of risks; 'science' cannot provide answer to the normative dimension (Joerges,




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2001, p. 3)? Not only in the members states, but also at the supranational level normative standardshave become a problem, for example, for social regulation of biotechnology and also with regard toembryo research in the fifth and particularly the sixth framework programme for RTD.(2)

Governance practices have to take these different dimensions into account and to balance theirinfluence in policy and decision-making. Cognitive approaches that focus solely on (scientific)knowledge and interests while ignoring the normative dimension are insufficient.

3 Biopolitics and the development of European TA

In this paper, I attend to a widespread definition of TA which includes, for example, technologicalforesight, parliamentary TA institutions, policy advice committees just as well as more deliberative

practices. The core of TA is to combine scientific evaluations of (new) technologies with their socialassessment. Policy-makers are a primary addressee of (formal) TA; a common goal is to inform themabout technological and social options and, thereby, to improve policy-making. This policy advicefunction is central to the concept of TA from it inception in the late 1960s; however, since the 1990sTA is reorienting towards the public sphere (cf. Joss, 2002; Weale, 2001). Simon Joss and Helge

Torgersen (2000, pp. 84f.) proclaim that

" the European landscape of policy analysis and TA seems to have changed remarkably.While only a decade ago, there were just a small number of institutions actively

pursuing participatory initiatives, nowadays there are dozens of organizations andindividuals engaging in such activities. To be sure, there are still critical voices, and

public participation is by no means fully established in institutional TA; but the issuehas certainly moved more centre-stage."

This turn to so-called participatory TA is, in fact, reflected on the supranational level. The briefhistorical reconstruction of this development and the predominant role biopolicies have played is the

focus of this section of my paper.

3.1 Development of European TA

The founding of the Office of TA (OTA) at the US-Congress in 1972 was the starting point for a firstwave in the institutionalisation of (parliamentary) TA in many West European countries and at theEuropean level (cf. Vig/Paschen, 2000). The EC gained importance for the institutionalisation of TAin Europe by helping to build up relevant networks and by promoting the cooperation oforganisations for TA founded in the member states (cf. Baron, 1995, p. 147). The programmeForecasting and Assessment in Science and Technology (FAST), set up in the mid-1970s, was afirst attempt to build a community method for planning and forecasting of new technologies. One

thematic focus of the FAST activities was the European 'biosociety'. The FAST group tried toformulate A Community Strategy for European Biotechnology. The effects of the FAST

programme were rather limited because of the lack of strong ties with policy-makers, and of a firminstitutionalisation within the community policies, especially RTD policy (Baron, 1995, 144; Weiler,1995, p. 149). Furthermore, the basic orientation of FAST, stressing societal demands, collided witha general enthusiasm for technology among conservative governments in the 1980s.

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For many years, the European Commission was the only institution attending to TA at the Europeanlevel, even though the European Parliament become interested early on. In the mid-1970 when the

parliamentary influence on European policies was still very limited, a proposal was made for a




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European Office of TA based on the OTA model which did not find the necessary support fromthe Commission; all attempts for a firm institutionalisation of TA were blocked (cf. Wennrich, 1999,

p. 529). With the rise of counter-movements against nuclear energy and biotechnology in the 1980sand with the growing importance of RTD policy established in the Single European Act in 1986, theEuropean Parliament took the initiative again. In 1987, a pilot project was set up for theestablishment of a European parliamentary organisation for TA. In order to fulfil the responsibilitiesof the European Parliament on issues of socio-technical change and to defy the strong position of theCommission, the Scientific and Technological Options Assessment Programme (STOA) wasfinally set up.(3) STOA became an integral part of the Parliaments administrative structure in 1992(Holdsworth, 2000). However, while the idea was to incorporate participation of the public and ofstakeholders as well as to create a public sphere, STOA followed in fact a strong expertise andinstrumental model of TA.

The effect of STOA on the work of the European Parliament has been, at best, limited. The reasonsare scarce financial and personnel resources, lack of continuity, the complicated institutional andcultural environment, unclear competences, an instrumental and science-driven focus, as well, asinadequate support by the Parliament itself (cf. Baron, 1995, 139ff.; Weiler, 1995, 163ff.; Wennrich,1999, pp. 532f.). Biotechnology and biomedicine have been areas of major concern for STOA,however with minor influence.(4)

3.2 Biomedicine a catalyst for the development of European TA

From the very beginning of European TA with the FAST programme, biomedicine was importantand centre-stage. In the 1980s, Parliament discussed the rapid development of biotechnology and

biomedicine several times, either in response to policy proposals by the Commission or on its owninitiative. Yet, it was the European Parliament and its objections to the Human Genome AnalysisProgramme, originally launched by the Commission under the provocative title predictivemedicine in 1988, that has incited and challenged the development as well as the function ofEuropean TA (Abels, 2000). With support from some member states in the Council, Parliamentseriously criticised the proposal for its title and its supposedly eugenic rationale. It demanded, amongother things, the establishment of a programme for the study of the ethical, social and legal aspectsof human genome analysis (ELSA) and a broad public debate. The concept of accompanying TA

became important for approval of the Commissions proposal in Parliament (and the Council). In thefinal programme proposal, ELSA became an essential part funded with one Mio. ECU for two years.ELSAs main task was to win acceptance for the programme and to soothe the interinstitutional and

public debate .

This pragmatic ad hoc procedure and the installation of expertise-oriented TA have had long-termeffects for the development of European TA. RTD policy, whose first rationale was to improve thecompetitiveness of European industry in a globalised economy, hitherto neglected normative andnon-technical values. Conflicts in RTD policy were conflicts of interest, not of values. This changeddramatically starting with the Human Genome Analysis Programme. In the following RTDframework programmes, ELSA studies covered the whole field of biomedical ethics and of

biotechnology. This means that around 1990, EC policymakers became receptive to the idea thattechnological innovations need to be socially robust to be successful. The presidents of theCommission, the Council and the Parliament decided that bioethics should become an integral partof RTD policy. Ethics and economy were no longer seen as opposing orientations, but asinterdependent factors. Nevertheless in the beginning an instrumental conception of bioethics

prevailed, as illustrated in the so-called Bangemann report on the competitive environment forbiotechnology (cf. Commission, 1991, p. 41).

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Besides the regulatory and internal market framework as well as funding policies, bioethics was nowconsidered to be of utmost importance for the market success of biotechnology. Interestingly, someyears later, the Commission interprets its policy shift as follows:

" It may seem surprising at first sight that the Commission supported research onbioethics and even fundamental research on bioethics. But these new activities are infact logically integratedinto the larger scientific research programmes of the EC Moreover, research on bioethics does indeed answer to a political needas bioethicalconsiderations are playing a growing role in political debate within the EuropeanUnion." (Biomedical & Health Research Newsletter Nr. 2/1995, p. 10; my emphasis)

The Commission was in a central position to confront these barriers. In the 1990s, it concentrated onthe following instruments:

1. The outcome of the Presidents meeting in 1991 was a Commission communication on theintegration of ELSA into all biotechnology and biomedicine related RTD activities. Bioethicsand TA were integrated into the regular mechanisms ofEuropean RTD policy, and fundingincreased enormously.(5) Bioethical research is expected to fulfil two main tasks: Firstly todevelop a set of guidelines for ethically responsible research funding; some research isexcluded from the RTD programmes (e.g. germ line interference and human cloning), forsome other provisions are set. Secondly, it should contribute to public debate and policydeliberation. Whether the studies are effective, and how to measure their success, is underdebate. According to a STOA evaluation, it is quite unclear what role the issue of public

policy relevance plays in the Commissions evaluation of the ethics research. In fact, it is notclearwhatrole bioethics research plays in such evaluations at all (STOA, 1998, p. 50). STOAwarns that the Commission perceives ELSA, Biomedical ethics and public perceptionfunding as merely a public relations exercise or sop to the concerned (ibid., p. 51).

2. Along with the reorientation of RTD policy came some organisational restructuringin theDirectorate-General for research. A special unit for ELSA was founded within the directorate

for life sciences.3. The Commission has revised itsstructure for policy advice. In the course of the 1990s, it

established several new groups for such purpose. The first such group was the Group ofAdvisers on the Ethical Implications of Biotechnology (GAEIB) set up in 1991; it consisted offirst six, then nine members from law, philosophy, medicine, biology. Its task was to identifyand define new ethical problems with regard to biotechnology, to assess these aspects and their

potential influence on society and the individual, as well as advise the Commission. In 1998,GAEIB was suspended and the new European Group on Ethics in Science and NewTechnologies (EGE, 2001) set up. The groups consists largely of experts from the samescientific disciplines as GAEIB plus informatics; its mandate to assess allnew technologies isconfined by the competences as laid down in the treaties.(6) Yet again, the common-market

approach to bioethics is evident:

" On the basis of the principles laid down in the European Treaties (which makereference to the fundamental rights defined by the European Convention of HumanRights of the Council of Europe), the EGE endeavours to draw up common rules toenable the internal market to operate in accordance with Europe's ethicalvalues." (EGE, 2001; my emphasis)

A further high-ranking policy group, the Life Sciences High Level Group consisting of elevenbiologists, was formed in April 2000 by Commissioner Philippe Busquin to inform the Commissionon new developments in the so-called life sciences, and to generate proposals on how to further the

dialogue between science and society.




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3.3 Characteristics of supranational TA and policy-making

Three conclusions can be drawn regarding the development at the supranational level from the 1970sto the late 1990s: Firstly, the European level relies on a instrumental and science-driven modelof

TA; generally, participatory structures have not been developed. The Commission sets up and makesuse of scientific advisory committees; it utilizes its organizational resources and experiences todecide who gets access to European policy networks and who doesnt. Policy- and decision-makingon issues of science and technology is, above all, a politics of expertise. Epistemic communities,that is networks of professionals with recognized expertise and an authoritative claim to policy-relevant knowledge, have easy and above all privileged access to European-level policymakers(cf. Haas, 1992; Zito, 2001). This has also become obvious in the EC comitology system dealingwith these questions (see section 4). Yet, as the sociologist of science Sheila Jasanoff (1990) hasforcefully argued: The nave vision of neutral advisory bodies 'speaking truth to power' should berenounced. It is this focus on expertise in RTD regulatory and funding policy that has led to theaccusation of technocratic governance suffering from a lack of public legitimacy (cf. Peterson,1995a; Radaelli, 1999; Zito, 2001).

Secondly, we can observe the rise of bioethics. The responsiveness to and emphasis on bioethics inEuropean TA is clearly rooted in the normative dimension of biopolitics moreover, bioethics andTA are often thought of as the same. This development is not unique to the supranational level, butethics has gained prominence in strategic decision-making and public policy in the member states aswell (cf. Lindsey et al., 2001; Salter and Jones, 2002). In the 1970s and much of the 1980s, the

predominant policy framing centred on risks; controversies were framed as scientific-technicaldebates. In the 1980s and, particularly, in the 1990s, we can see a fundamental change towardsethical framing of policies. Since 1997, ethics has taken centre stage in public, policy and mediadiscourse. This is also obvious at the European level, if we look at the Council activities. Shortlyafter the cloning of Dolly the sheep, the Amsterdam Council accepted a resolution that prohibitsthe cloning of human beings. The Council requested that the Commission considers this aspect in the

patenting directive, which was still under debate. The position against reproductive (as opposed toso-called therapeutic) cloning was confirmed in the Charter of Fundamental Rights first acceptedat the Nice Council in December 2000, then acknowledged by the Commission and the EuropeanParliament.(7) In addition, for the first time in EU history, the Stockholm Council in June 2001called attention to the need for a broad and open ethical debate on biotechnology as one of the mostimportant technologies for Europes future; bioethics should become an integral part of theinnovation process (Swedish Presidency, 2001). With regard to RTD policy, until the end of 2003the Council has to come up with shared ethical guidelines which regulate the funding of sensiblefields such a embryo research. Finally, the outstanding position of ethics is also reflected in thechanges introduced in the regulatory framework. For example, the new European Parliament and

Council directive 2001/18/EC on the deliberate release of GMOs speaks of the possibility ofintroducing an ethical expertise into the regulatory procedure (see section 4). However, this turntowards bioethics poses new challenges for Community policy- and decision-making; currentgovernance practices prove inadequate for these issues.

Thirdly, since the days of Commissioner Edith Cresson, the Commission has tried to take thesocialrerequisites of technological innovations into account. John Peterson and Margaret Sharp point out:

"The diffusion of innovations involves constant change and a reciprocal mouldingprocess between technologies on the one hand and societies on the other. Yet,technology policy is a uniquely technocratic area of policy in which experts are

powerful and the general public is not. Efforts by the Commission under Cresson tomake EU-funded research more socially relevant and sensitive to the 'needs of society'reflect a new and general enthusiasm for open debates about how technology policy can




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serve broad social needs." (Peterson/Sharp, 1998, p. 20)

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Including bioethics and integrating a wide range of scientific disciplines into the structures of policyadvice was a way to tackle the growing sensitivity to social innovations. According to ChristineLandfried (1997), these changes suggest a transformation of the Community beyond technocraticgovernance. However, it took some more years until a deeper policy shift began to mature.

4 Regulatory biopolicies between science and participation

The historical changes outlined so far with regard to RTD policy influence the approach toregulatory issues. The development and dominance of regulatory policy has been widely discussed

by scholars of European integration. Furthermore, the regulation of risks and the role of scientificexpertise in decision-making, in particular with regard to food and technical standard-setting, has

been a major topic (e.g. Joerges et al., 1997). Recently, outstanding institutional and policy changeshave been introduced in EU risk regulation so that David Vogel (2001) speaks of a new politics ofrisk regulation. Biopolitics and above all the controversy over GM food has fostered these changes.

Since the 1990s, the EC has become the most important actor for the regulation especially ofbiotechnology; it has developed a vertical and horizontal, process and product-related regulatoryframework focussing on the special risks inherent in these new technologies. However, it is essentialto distinguish the Communitys regulatory competences with regard to biopolicies. The EC Treatyassigns broad competences to the supranational level for biotechnology, while they are very limitedin the area ofbiomedicine.(8) Health policy (of which biomedical policy is part) is still for the most

part a national domain. Yet, some Treaty articles allow for measures related to biomedicine,

especially in relation to research funding. So far, the main role has been to encourage biomedicalRTD, which has become a controversial issue in the context of human genome research and,recently, embryo research. Yet, for one aspect the EC has strong regulatory power and that is

pharmaceuticals. Since the early 1960s, the EC has harmonised the marketing authorisation forpharmaceuticals, and in 1995 two new procedures were introduced, one specifically forpharmaceuticals derived from genetic engineering (cf. Feick, 2002). While the new regulatoryregime still allows for national authorisation procedures and subsequent mutual recognition, biotech(and all other innovative) pharmaceuticals have to go through a centralised procedure requiringapproval by the European Agency for the Evaluation of Medicinal Products (EMEA) and leading touniform and binding European decisions. Since drug development is a very long-term (and high-risk)

process (it takes 10 to 15 years from the laboratory to clinical practice), and since the pharmaceutical

sector has only started to invest in this development in the 1990s (this is partially an outcome of theHuman Genome Project), more and more pharmaceutical will have to be authorised under thiscentralised procedure in the future.

In biotechnology, distinctive and rigorous regulation has been developed since the 1990s pertainingto agriculture and food. The first two Community directives addressed the contained use of GMOs(Council Directive 90/219/EEC) and their deliberate release (Council Directive 90/220/EEC). Thelatter directive regulates experimental as well as market release of GMOs; it has become thecornerstone of Community regulation and was under massive critique from the very beginning (cf.Cantley, 1995; Gottweis, 1999; Patterson, 2000). Especially the market release of GM food andcrops has led to massive conflicts at the supranational level, particularly via the comitology regime,

that is, the complicated implementation procedure involving the competent national authorities andthe Commission in the regulatory process. Christian Joerges and Jrgen Neyer (1997) claim thatcomitology committees are usually an efficient means of social regulation by transforming strategicinteraction into deliberative problem-solving. Thereby, according to Joerges and Neyer, they




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constitute a special way of legitimising Community policies beyond the dichotomy of input versusoutput legitimacy. With regard to GMOs, however, rational deliberation and normative reasoningfailed: In all cases where a competent authority approved the market release of a GMO, a competentauthority in another member state raised objections and in so doing initiated the comitology

procedure. This was because the mutual recognition of risk assessment demanded by the directivedid not occur since competent Authorities do not trust the risk-assessment carried out by otherCompetent Authorities. (Toeller/Hofmann, 2000, p. 40) Material criteria for risk assessment andmanagement, which are not fixed in the directive itself, were contested among the members of theArticle-21 Committee in charge. The situation escalated with Ciba Geigys bt-maize in 1996: afterhaving consulted several scientific committees supporting the Commissions position pro marketrelease, the Commission authorised the bt-maize against the outspoken will of 14 member states.(9)This incidence contributed, firstly, to an institutional reform of the comitology system itself (cf.ibid.), and, secondly, to a policy change: since 1999 there is a de facto moratorium for placingGMOs on the market.(10) The moratorium stressed the urgent need for a revision of the deliberaterelease directive which was finally adopted in early 2001 (EP/Council Directive 2001/18/EC). Thenew directive, coming into force in October 2002, attends to strong public concern and makestransparency as well as public participation in the national authorisation procedure compulsory.(11)Still, the new directive has not yet led to a lift of the ban on GMOs.

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GM food has proved to be most controversial. Especially due to the BSE crisis and its mobilisingeffect on domestic publics, food safety has become the prominent policy frame. Vogel (2001, p. 13)states that mad-cow disease has shaped the way Europeans have framed the potentials risksassociated with GMOs.(12) The principle of mutual recognition applied also to GM food until theso-called novel food regulation (Regulation 258/97) was adopted in 1997 again after years ofintense debate (for a detailed reconstruction cf. Rckert, 2000). It introduced a harmonised, two-step

procedure involving national food agencies and the Commission; accompanying regulationsconcerned, above all, labelling standards (cf. also European Commission, 2002b). Nevertheless, theregulation proved insufficient and some member states used the safety clause to ban the import ofGM food. Finally, in 2000 the Commission proposed a new regulatory regime for food in its White

Paper on Food Safety (European Commission, 2000e; cf. also European Commission, 2000d). At theheart of this new regime is the independent European Food Safety Authority (EFSA) formallyadopted on 28th January, 2002. EFSA is of chief importance for the GMO debate, because it will

provide scientific opinions on any issue related to GMOs (European Commission, 2001h, p. 2). Thecrucial aim is to win back public trustin the Communitys ability to effectively manage the risks

posed to the environment and human health.

In addition, the Commission proposed two new regulations in 2001 focussing on the traceability andlabelling of food (ingredients) and feed that consist of, contain, or are derived from GMOs(European Commission, 2001f; European Commission, 2001g). It suggests establishing a 'one door one key' principle for the authorisation procedure of food and feed involving EFSA along withtraceability and labelling of GMOs from the farm to the fork. As Commissioner David Byrnecomments on the first reading in the European Parliament, the proposals provide the right approachto foster public confidence and social acceptance of the application of biotechnology in agri-food

production. They will also give legal certainty for business operators as well as facilitating trade.(European Commission, 2002c)(13)

The emerging food regime deserves some further consideration, particularly in comparison to other

countries such as the US, where regulatory agencies have been introduced as a response to theregulatory crisis of the 1960s and 1970s. A characteristic feature of the EU food regime is that itdistinguishes between risk assessmentand risk communication, which is the duty of EFSA, and risk




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management, which is a privilege of the policy-makers. This distinction has ambiguous and evencounter-productive effects as, for example, Giandomenico Majone, Ed Randall, and David Vogelargue in their critique of the new regime.

Majone is certainly one of the most important and outspoken advocates of regulatory policy andstrong regulatory agencies in the EU (cf. Majone, 1996). In a recent article he has criticised theemerging European food safety regime. According to him, the EFSA structure reflects the changingmeaning and the ambiguity of the precautionary principle. First introduced in the Maastricht Treatyin the chapter on environmental policy, the precautionary principle has been broadened to cover allhuman, animal and plant health. In its Communication on the precautionary principle (EuropeanCommission, 2000a), the Commission assigns it the status of a 'central plank' of Community policyand, more ambitiously, the status of a general principle of international economic and environmentallaw (Majone, 2002, p. 90). Majone claims that this principle has many theoretical as well as

practical weaknesses, above all the lack of a clear definition besides the unclear effects on regulatoryscience, on integration and diversity as well as on free trade. He argues that the emphasis on the

precautionary principle and the key status assigned to it could be interpreted as a strategy to avoidor at least delay difficult institutional choices (ibid., p. 107). He suggests establishing strongregulatory agencies with powers of rule-making andrule enforcement based on the US model offederal agencies.

Majone reasons that the distinction between scientific risk assessment and political risk managementleads to a politicisation of food safety which restricts the credibility of the new regulatory institution.This is, of course, of paramount importance in an already highly politicised policy area such as

biotechnology and GMO where public opinion is highly divided and where some member stateshave an outspoken anti-biotech position due to the public controversy (resulting, for example, in animposition of national bans on GMO products). This politicisation argument is supported by EdRandall, who asserts that it brings about the real danger of secrecy and intergovernmental pork-

barrel politics.

9

"The real concern of those who believe that a sharp distinction between risk assessmentand communication and risk management is unsound is a well founded fear that thesquabbles and national rivalries and suspicions that have characterised EU decisionmaking and risk management in the recent past will undermine the authority of both theEFA (European Food Authority; G.A.) and the Commissioner for Health and ConsumerProtection in the future." (Randall, 2001).

Yet, credibility of the new regime is an important issue. Vogel contributes an historical argument; hestates that the current style in EC risk regulation resembles the risk-averse US approach during the1960s and through the mid 1980s. In the US, strong regulatory agencies helped to reconstitutecitizens trust in the states capacity for successful risk management. Vogel implicitly assumes thatthis is a viable course for the Community as well, since the EC and US polity share importantsimilarities such as a division of power in a multi-level system (Vogel, 2001, p. 18; cf. also Randall,2001).

While these critical analyses certainly shed light on some most important aspects of the currentdebate, in my opinion, they do misjudge to some extent the nature of the problem and its institutionalcontext. Firstly, the current regulatory crisis is not limited to the EU and its member states alone.(14)

The resistance to GMOs has influenced biopolitics far beyond the EU, for example with regard toworld trade (cf. Skogstad, 2001), but also international food aid.(15) Martin Bauer and GeorgeGasekell (2002) speak of the making of a global controversy which is, to some extent, induced by




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the critical European public; the EU debate does have impacts on the US debate. Jasanoff (2000)observes, in fact, a crisis of expertise in the US just as in Europe. However, the political responsesdiffer: The debate in the US focuses on the role of experts, on policies, and on specific issues such as

biotechnology. The European debate, in contrast, is about the status of science in general, new formsof governance, institutional reform and the need for changing the relationship between science andsociety. Yet, participation is considered an adequate response in the EU as well as in the US.(16)

The EU focus on governance and institutional change is linked to a second aspect: the state of itsolity and fundamental differences to the US. The establishment of strong regulatory agencies in the

US was, of course, a major and, according to Vogel, also successful institutional intervention.However, they were introduced into a historically grown political system with well establishedmeans for securing legitimacy, e.g. by introducing a system of notice and comment which allows fortransparency and responsiveness of the regulatory system. These agencies work, in general, quitewell in the field of biotechnology so that opinion polls show that the level of trust in the regulatoryagencies is higher in the US than in the EU (cf. Gaskell et al., 2002). Yet, the conditions for choosingsuch institutional solutions are different in the EU: it is an evolving, dynamic and hotly disputed

political system of intergovernmental and supranational character which poses new challenges forthe problem of democratic legitimacy. It cannot rely as much on generalised public trust and supportsince it still has to develop ways to channel public opinion into supranational policy-making. Thehistory of the biotech controversy shows that the existing institutions do have the capacity to channel

public opinion, but it is limited and so far it has not been successful in terms of resolving theconflict.

The limited capacity has to do, so I believe, with the nature of the conflict and its strong normativefoundation. The argument that risk assessment and management are inseparable and should be in onehand, that is, the regulatory agency, is after all based on a cognitive and positivist premise thatdoesnt sufficiently take the normative (and sometimes even ethical) dimension of technologicalconflicts into account. It underestimates the influence of norms in regulatory science and considersscience-based knowledge as the only legitimate source of regulatory knowledge production and

decision-making. However, a normative dimension is inherent in all social regulation, but it is ofparticular importance with regard to biopolicy. In her discussion of European agencies Ellen Vospoints out that at least in situations of scientific uncertainty the non-majoritarian governancemodel based on independent technocratic agencies clearly fails to recognise the value-laden nature ofhealth and safety and environmental regulation (Vos, 2000, p. 19; cf. also Neyer 2000; Joerges2001). Moreover, normative premises are often, indeed, part of the assessment procedure itself;therefore, there has to be a political debate. The dominant public view of the EU is already that oftechnocratic decision-making. Efforts to depoliticise a debate that is inherently political will notsolve the basic problem.

10

This is also the official Commissions position; it claims that the separation of risk assessment andmanagement allows the necessary inclusion of other factors than science.

"It is recognised that scientific risk assessment alone cannot, in some cases, provide allthe information on which a risk-management decision should be based, and that otherfactors relevant to the matter under consideration should legitimately be taken intoaccount including societal, economic, ethical and environmental factors and thefeasibility of controls. (European Commission, 2000d, p. 28) (17)

The EFSA structure in my opinion tries to reflect some of these aspects by establishing a corporatiststructure integration stakeholders and policy networks with national authorities, as well as by




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communicating risks to the public.(18) The Commission states that the work of the EFSA shall betransparent for the public (European Commission, 2000d, article 37); furthermore, it shall developappropriate contacts with consumer representatives and any other interested parties (ibid., article41) and the management board shall include representatives of consumers and industry (ibid., article24). However, so far it practically not clear who should be involved in the production of regulatoryknowledge, in which way and to what ends; the Commissions statements are still very vague. Thisis not to say that there should not be regulatory bodies, there is of course an urgent need. Thenormative and the science-based assessment are complementary; the normative assessment doesrequire a science input. Yet, both modes of assessment of technological risks do operate under theDamocles sword of uncertainty and the intrinsic lack of knowledge (cf. Bora, 2002). Whether or notthe EFSA will be efficient in solving or channelling the biopolitical debate is still an open question.If it is to be successful, it is important to consider how it fits into the overall governance design andthe ongoing participatory shift in the EU.

5 Contextualising the participatory shift: ReformingEuropean governance

The reform of European governance has held top priority on the agenda since early 2000. Thecurrent crisis to which the Community is attempting to respond is not limited to risk regulation only,

but is essentially part of the deep democratic deficit of the EU and its legitimacy crisis. This is thereason for the prominent place of risk regulation and biopolitics in the White Paper on Governanceand related policy papers the Commission has published in the last two years. One of the moststriking features these policy papers share is their participatory speech: They emphasise the needfor input legitimacy and take this as a means for strengthening output legitimacy. They are allconcerned with new institutional and procedural mechanisms for more participation by creating a

public sphere and including stakeholders, the general public and citizens in Community policy-making. Science and technology in particular, biotechnology assume a prominent place; it is inthis context that the Commission speaks of the need for a new societal contract. While this focus

on participation is itself very remarkable, a closer analysis of what participation means in thiscontext and how it is operationalised reveals that the Commission basically applies a very limitedconcept that can be characterised as participation via consultation rather than participation as usedin theories of, for example, participatory democracy.

5.1 Challenges and principles of European governance: the White Paper

The long awaited White Paper on European Governance (European Commission, 2001a) addressedto the Member States, public authorities, and civil society provides the most general outline of theCommissions view of the problem.(19) For the Commission, the starting point is that peopleincreasingly distrust institutions and politics; this is particularly acute at the level of the EuropeanUnion (ibid., p. 3). The goal of the White Paperis to open up policy-making to make it moreinclusive and accountable. A better use of powers should connect the EU more closely to its citizensand lead to more effective policies. (Ibid., p. 8) For the Commission there is a very strong link

between input and output legitimacy. Key principles of good governance referring to inputlegitimacy are openness, participation, and accountability. In the Commissions vision, consultationof and dialogue with civil society, that is a wide range of interest groups, associations and grass-rootsorganisations, enjoys a prominent role, because civil society plays an important role in giving voiceto the concerns of citizens and delivering services that meet peoples needs (ibid., p. 14).

11

At first sight, it seems striking that the Commission is adopting such an input approach. Scholars of




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the 'democratic deficit', such as Fritz W. Scharpf (1999), raise serious doubts that the EU fulfils thenecessary systemic prerequisites for input legitimacy; according to Scharpf, the EU can only rely onoutput legitimacy. The options laid out in the White Paperraise the question as to why theCommission is advocating a participatory governance model. In the past, the Commission has

proved a very successful architect of policy networks. These networks allow the formal and informalinteraction of public and private actors from a heterogeneous background. The networks aresometimes very open, inclusive and bottom-up but often very elitist, exclusive, and top-down(Kassim, 1994; Peterson, 1995b). Experts, i.e., scientific experts as well as representatives of interestgroups(20), do take a central position in these policy networks, because the Commission dependsheavily on external expertise. The remarkable committee system is the main route via whichexpertise is integrated (cf. Pedler and Schaefer, 1996; van Schendelen, 1998; Christiansen/Kirchner,2000).

Bearing this in mind, the Commissions commitment to a participatory approach is less amazing,since it puts the Commission in a central position as a policy-broker. In this sense, theinterinstitutional battle for policy-making power as well as shifting weights in favour of theEuropean Parliament (due to the co-decision procedure) are the background for the Commissionsvision of European governance (cf. Hritier, 2001; Laffan, 2002; Wincott 2001). The Commisionattempts to gain back lost ground by promoting a concept that puts itself in a key position.

In the White Paper, the Commission considers the relation between science and society a crucial areafor European governance (cf. European Commission, 2001b), explicitly mentioning biotechnology.Policy-making and regulation rely very much on expert advice, but biotechnology has illustrated thatadvice beyond 'pure' science is necessary, and that there is need for public confidence in expert-

based policy-making (cf. ibid., p. 19). The Commission suggests a multi-disciplinary expert systemand the creation of a European scientific reference system to support community policy-making, inorder to democratise expertise. In so doing, it can handle the challenges, risks and ethical questionsthrown up by science and technology (ibid., p. 33). In the final analysis, a lack of public confidenceis the fundamental problem for the Commission. Hence, the task of the Community institutions,

above all the Commission, and of experts is to rebuild this confidence by integrating the citizenry.The next question is: How is this 'trust model' further elaborated in the sectoral policy papers onscience and society?

5.2 Science and society sectoral visions for European governance

In addition to the White Paper, the Commission has published several sectoral papers, for instancethe Communication on the European Research Area (ERA) that address general questions ofgovernance in RTD policy. It has furthermore published papers on the relation between science andsociety. Les Levidow and Claire Marris (2001, p. 348) claim that these papers indicate a change inthe Commissions own view of the science/society relation from public ignorance to loss of trust.So far, the Commission has attributed societal opposition and resistance to biotechnology to a lack of

public understanding, to peoples fear and ignorance (cf. Commission, 1991), now trust is the newcatchword. This 'trust model' already mentioned in the White Paperrequires a new tools: bettercommunication between researchers, industry, policymakers and citizens and participation.

In theERA papers (European Commission, 2000b; European Commission, 2000c), the Commissionstarts with a negative diagnosis of the current situation for research in Europe. The Community is atrisk of losing the race for growth and competitiveness in a global economy, Europe might notsuccessfully achieve the transition to a knowledge-based economy (European Commission, 2000b,

p. 4). Science and technology, and particularly biotechnology, are vital for such transition. However,the public image of science is less positive than it was. Scientific progress seems to inspire as much

anguish as hope (ibid., p. 5). It is this context, when the Commission suggests new modes forgoverning RTD, particularly a harmonisation of (so far) complementary and often competingresearch policies between member states and the Union. I do not want to address the problems this




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brings along for the adjustment of national RTD policies. Instead, I am interested in how theCommission perceives the relationship between science and society. In theERA Communication, theCommission attends to this problem in the final (!) chapter, An area of shared values. Itrecommends developing new and sustained forms of dialogue between researchers and other socialoperators (ibid., p. 20). The Commission refers to consensus conferences, an instrument of TAknown for its radical participatory approach, organised at European level on issues emerging at thatlevel as a means for ordinary citizens to express their opinions and concern on issues of scienceand technology (ibid.) at least experimentally (European Commission, 2000f, p. 16).(21)Furthermore, the ethical dimension especially in fields such as life sciences regarding issues suchas cloning or embryonic tissue could be strengthened by establishing closer links between ethicscommittees set up at the national and European levels (European Commission, 2000b, pp. 20f.).

12

In the policy paper on science and society as well as in the action plan, the Commission furtherelaborates this concept (European Commission, 2000f; European Commission, 2001d). It repeatedlyconfirms the need for a new partnership (European Commission, 2001d, p. 4) by promoting opendialogue between researchers, industrialists, policymakers, interest groups and the public (EuropeanCommission, 2000f, pp. 6, 16) especially at the European level, but also at the national, regional andlocal levels (European Commission, 2001d, pp. 12f.). The Commission denounces a simplistic andlinear model of technological innovation from scientific invention to useful application;technological innovations are recognised as outcomes of social networks that incorporate a widerange of social actors, including users (ibid., p. 8). People should be involved, particularly indefining the priorities of publicly-funded research via consultative and advisory bodies (ibid., pp.8f.) in order to bring science policy closer to the citizens (European Commission, 2001d, pp. 5,14). The experiences with participatory research policy-making a supplement to formal decision-making , now need to be widened and deepened to systematically include other sectors of civil

society at all stages (ibid., p. 14).

Levidow and Marris welcome the Commissions initiative, but they are most critical about the waythe science/society issue is dealt with. According to them, this new rhetoric of openness is double-edged and contradictory, because participatory talk often just covers the former 'deficit model':

"the new focus on a crisis of 'confidence' has not entirely abandoned preconceptionsabout misplaced fears or public ignorance. On the one hand, official proposals for'stakeholder dialogue' are put forward as a novel approach, developed from lessonslearnt from past paternalistic institutional behaviour. On the other hand, they continue toframe the problem as a gap between scientific knowledge and public anxiety

presumably a gap between rational judgements and irrational concerns. 'Public debate'and 'input from society' are sought mainly as a means to restore the legitimacy ofscience and technology, not as a means to reconsider innovation

processes." (Levidow/Carr, 2001, p. 348)

They continue that

thus, in these official discourses, public distrust is often still attributed to deficientpublic knowledge of science. Consequently, better communication is still seen as a keysolution (ibid.).

While ethical concerns are now taken into consideration, they are believed to be extra-scientific.Scientific and other arguments are characterised as separable. While the first are still perceived to beobjective, the last one is attributed to the subjective realm and are, therefore, of secondary




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importance only (ibid., p. 349). This keeps the notion of value-free science and scientists alive;expert advice is too often simply equated with science. In so doing, the public is still the source ofthe problem; but in accordance with Levidow and Marris, this is a fundamental misdiagnosis.(22)The authors conclude that the perception of science and technology as objective basis for

policy (ibid., pp. 356f.), in fact, does create the legitimacy crisis. Yet, if the aim is to relegitimisedecision-making, government will need to 'un-learn' many institutional assumptions and to redefinethe problem at stake. Rather than seeking ways to change the public, it is necessary to change theinstitutions responsible for promoting innovation and regulating risks. (ibid., pp. 357f.)

To them, wider participation of lay-people should not be restricted to the assessment of innovationsonce there are near to the market, but to trajectories in research policy in general.

13

5.3 Visions for the governance of biopolitics

I presume that biopolitics puts models for European governance in the field of science andtechnology to the test. As declared by the Commission, GMOs, and more specifically transgenic

plants, have come to symbolise all that is wrong in the relationship between science andsociety (European Commission, 2001e). In order to break the deadlock (ibid.), it has recently

published a document Life sciences and biotechnology A strategy for Europe (EuropeanCommission, 2002a). The Strategy Paperis the outcome of a consultation process the Commissioninitiated with its Consultation DocumentTowards a strategic vision of life sciences and

biotechnology (European Commission, 2001c). This document is an expression of the newgovernance strategy. The Commission invited comments from citizens, consumers, as well asorganised civil society, scientists, public authorities and operators with economic interests inindustry, agriculture of services to contribute to the Commissions reflections (ibid., p. 5). In theConsultation Document, the Commission outlines basic problems and questions on a range of issuesrelated to biotechnology, from ethical implication, to regulation, public involvement to trade,international collaboration and development policy.

The document starts from the assumption that the life sciences have a vast potential for ensuring thecompetitiveness of European industry (ibid., p. 3f.). The challenge is to transform research into new

products and services; the successful transformation requires a society fully committed totechnological innovation.

Most importantly, this potential can only be realised if there is broad public support. Consequently,there is increasingly a need for awareness and enlightened policy decisions on the societal priorities,and in particular on thesocietal frameworkand the ethical basis for development and applications ofthe new sciences and technologies. (Ibid., p. 4)

Ethics as well as social or economic implications biotechnology are perceived to be of keyimportance for public perception and, therefore, they have to be properly dealt with. The key tosuccess lies with all stakeholders in Europe public authorities, science, economic operators andconsumers as well as the general public. (Ibid.) In short, the issue of science and society is thoughtto have a direct effect on Europes economic future. The Commission concludes that the life sciencesare of strategic importance for Europes quest to become a leading knowledge-based economy an opportunity Europe cannot afford to miss (ibid., p. 27). The broad public debate hasdemonstrated the challenge to find socially acceptable solutions. Therefore, the key to resolve theapparent dilemmas lies with Europes citizens, and that is why the Commission invites comments toits policy proposal.




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In the Strategy Paperand the attached action plan, the Commission takes up the somewhatdeterministic vision for biopolitics: the choices for Europe are either a passive and re-active role,and bear the implications of the development of these technologies elsewhere, or develop pro-active

policies (European Commission, 2002a, p. 3). The Commission holds uncertainty about societalacceptance responsible for the lack of attention to biotechnology in Europe, which, in turn, has hadnegative effects on economic performance. The basis question is: How can Europe delivereffective, credible and responsible policies which enjoy the confidence and supportof itscitizens? (ibid., p. 5; my emphasis). Ethical and societal implications are important to consider. Yet,the choice for the Community is not whether, but how to deal with the challenges posed (ibid., p.3).

Chapter 4 of the Strategy Paperdeals with the science/society issue; here the Commission refers toitsAction Plan discussed above (European Commission, 2001d). Governance of biotechnology, thatis the way public authorities prepare, decide, implement and explain policies and actions (ibid., p.11), is called a key element for responsible policy. For the Community, five lines of action areimportant: societal dialogue, a development in harmony with ethical values and societal good,demand-driven applications, public confidence through science-based regulation, and respect forCommunity and international regulatory principles and legal obligations. The Commission stressesthe need for constructive and meaningful dialogue open to all stakeholders, which has to bebalanced and rational (ibid., p. 12). It distinguishes between real issues and false claims,without explaining how to draw this distinction. Who is to decide which is which? The keysignificance of the dialogue is to help the public and stakeholders better understand andappreciate (ibid., p. 13) the complex issues raised by biomedicine and biotechnology. Yet, theCommunity should actively pursue this dialogue; it should be on-going, and not restricted to productregulation only. In the action plan annexed, the Commission announces its intention to take theinitiative for establishing a broadly based Stakeholders Forum and for encouraging public debates(Action 13). The Commission wants to strengthen research into socio-economic and ethical issues(Action 14). Furthermore, it aims to help identify areas for possible consensus on ethical principles,above all in relation to biomedical applications (e.g. stem cell research, genetic testing); it proposes,

where appropriate, to set up self-regulatory guidelines for scientists and industry (Action 16).

14

The Commission stresses the role of the bourgeois rather than the citoyen orcitoyenne in sciencepolicy: the consumer should decide what products to buy on the basis of informed choice, andthereby influence the technological trajectory (cf. ibid., p. 14). For regulation based on scientificassessments, building public confidence and understanding must be a permanent concern (ibid.; cf.also ibid., p. 16). The scientific community has to take a central position in this dialogue, since it has

to explain the scientific background to the public (while industry needs to explain the benefits ofproducts).

6 Conclusions

The Commission has recently turned to the issue of European governance and introduced someproposals for changes in the way, the EU can enhance its policy performance. The Commission hasoperationalised some of its ideas for the field of biopolitics; its proposals are dressed in a remarkableparticipatory talk. At the same time, it has tried to implement some of the changes is suggests; thenew food safety regime takes a prominent place.(23) However, the Commission proposals are based,

firstly, on a narrow concept of participation and, secondly, the shift from a deficit to a trust-basedmodel in the field of biopolitics does have its pitfalls. Participation, according to the Commission,implies getting all kinds of social actors involved in supranational policy-networks; indeed, this

basically means top-down consultation of sectoral stakeholders. Some scholars question, if this is




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actually a shift at all; Paul Magnette, for example, criticises that the Commission does neither breakwith the classical methods, nor with the philosophy which underpins it Participation can only beinitiated by the institutions, it is limited to non-decision and mainly directed towards sectoral actors.(Magnette, 2001, p. 5) The various governance papers, particularly the White Paper, do notsufficiently if at all address the question of the practical realisation of this participatory shift,especially with relation to policy issues involving risks. Scharpf (2001, p. 7) even argues that sincenot a word is lost on the practicalities of Europe-wide participation, one might wonder about theseriousness of the invitation itself. One of the few concrete instruments mentioned for citizens

participation are consensus conferences; however, they are practically very difficult to conduct onthe supranational level. The advantage of this instrument is that it would allow deliberation betweenexperts, citizens and Eurocrats and help to create a sectoral European sphere.

Furthermore, this shift from deficit to trust is not per se a positive development because it does notsufficiently address the relationship between trust and knowledge in risk regulation. First of all, thetrust model covers up what is, at least partially, the 'deficit model': confidence and understanding arementioned in concert. Yet, understanding can be a major source of distrust. The Commissions

policy is not coherent: While it argues for a separation between risk assessment and managementwith regard to the food safety regime, in the policy papers on biotechnology it distinguishes betweenreal scientific and false non-scientific claims. However, who should draw the line? This modelassumes that trust in the authorities (e.g. regulators, policy-makers, science) is a better source forcreating legitimacy than knowledge. Yet, trust and knowledge are closely interlinked in many ways.How much knowledge and how many control mechanisms does trust require, if we do not want tostick to a model of 'blind trust' and fall back on a paternalistic view of the Commission as a

benevolent dictator (Scharpf 2001, p. 7)? What does trust imply in a policy field where diversenormative orientations and even ethical considerations are as important as opposing interests aswell as intrinsic limits to knowledge? How much trust is required in the regulators ability to dealwith the lack of knowledge and the omnipresence of uncertainty? And how much authority overthe dimension of true science v. value-loaded conflicts does transnational decision-makingrequire in order to be effective (Joerges, 2001, p. 15)? Finally, does participation help to build trust

or could it even diminish the trust in authorities? The Commission does not attend to these issues anyfurther.

15

The relationship between input and output-oriented legitimacy is essential for the debate onEuropean governance. The choice is not either input or output, since the deficits are on both sideswith regard to biopolitics. There are surely options for improving the output side in science-based

policies without considering participatory means via established (or new) political institutions, for

example, by transparent and coherent policies within the comitology regime or by regulatoryagencies. Nevertheless, participatory means may help to improve the legitimacy. However, therelation between participation and legitimacy claiming that more participation leads to better

policies and thereby to more legitimacy is, in fact, much more complex than the Commissionassumes in its various policy papers. Participation guarantees neither legitimacy nor trust.Participatory structures do have their own restrictions. Who can participate when and where, underwhich conditions, and in what? Moreover, an emphasis on input-oriented methods can even havecounterproductive and delegitimising effects given the complexity of the EU and the various sourcesof its legitimacy (cf. Hreth, 1999). Inefficient outcomes of participatory processes can have adelegitimising effect on the procedure itself. Participation can, at best, serve as a complementtoother means of representative democracy, especially in a political system such as the EU where

participatory procedures are very hard to develop given the multi-level nature of the system and theabsence of a European public sphere. The lack of this broader contextualisation of the legitimacyproblem and of its practical difficulties is a major blind spot in the Commissions vision.




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Biopolitics will remain on the agenda of the EU: The debate on the regulation for traceability andlabelling of GM food and feed has only started and there is also growing need for a harmonised

policy in some areas of biomedicine, which is not restricted to the contested area of embryo research.In many EU member states, biopolitics has become a field for political experiments with alternativeways to create legitimacy which require deliberation between experts, citizens and policy-makers inorder to solve the dilemma of science v. society. It could also serve as an experimental field at thesupranational level. Therefore, the significance of the new food safety regime goes way beyondsectoral innovations in institutional design and legitimacy-building, but it could be a test case for theopportunities of participatory European governance and in this way may teach us some lessons forthe broader issue of EU legitimacy.

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